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compatibility studies – livogen pharmed

compatibility studies

Conducting comparability studies is critical for the development, manufacturing, and marketing of biopharmaceuticals to evaluate how closely biosimilar drugs resemble the reference drug. Comparability studies often include protein characterization assays and the Common Technical Document (CTD) of the biosimilar drug is significantly influenced by these studies. The Livogen Pharmed Company has established a framework for conducting comparability studies and is continuously expanding these services. Depending on the tests that are requested by customers, comparative studies are performed. The tests confirm that a change in a manufacturing process will not have a negative impact on the quality, safety, or effectiveness of biopharmaceuticals. According to the ICH Q5E comparability criteria for biotechnology/biological products, comparative studies must provide analytical certainty that the drug substance or drug product has remarkably similar quality characteristics both before and after process changes. We offer these services with authorized analytical reports and certificates. Compatibility studies: Identification and Classification of Proteins The N- and C-Terminal Sequencing Peptide Mass Fingerprinting Disulfide Binding Pattern Analysis Post-Translational Modification (PTM) Analysis (such as phosphorylation, glycosylation, and methylation) Primary, Secondary, and Higher-order Structural Studies Physicochemical Quality Analysis Biological Activity Analysis Immunogenicity Analysis Purity/Impurity Profile Analysis Intact Mass Spectrometry Determination

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